Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.

Time Frame

48 Weeks

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The analysis population is based upon the All Patients As Treated (APaT) approach

Reporting Groups

Description

MK0518 100 mg b.i.d.

Cohort I-Monotherapy Phase

MK0518 100 mg twice daily (b.i.d.)

Cohort II Combined-Combination Therapy Phase

MK0518 100 mg + tenofovir + lamivudine

MK0518 200 mg b.i.d

Cohort I-Monotherapy Phase

MK0518 200 mg b.i.d

Cohort II Combined-Combination Therapy Phase

MK0518 200 mg + tenofovir + lamivudine

MK0518 400 mg b.i.d.

Cohort I-Monotherapy Phase

MK0518 400 mg b.i.d.

Cohort II Combined-Combination Therapy Phase

MK0518 400 mg + tenofovir + lamivudine

MK0518 600 mg b.i.d.

Cohort I-Monotherapy Phase

MK0518 600 mg b.i.d.

Cohort II Combined-Combination Therapy Phase

MK0518 600 mg + tenofovir + lamivudine

EFV Combo Therapy

EFV Combo Therapy Phase - Cohort II

efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine

This arm included participants from Cohort I who were randomized to placebo.

Measured Values

MK0518 100 mg b.i.d.

MK0518 200 mg b.i.d

MK0518 400 mg b.i.d.

MK0518 600 mg b.i.d.

EFV Combo Therapy

Number of Participants Analyzed
[units: participants]

39

40

41

40

38

Number of Patients With Serious Drug-related CAEs
[units: participants]

With Serious drug-related CAEs

0

0

0

0

0

Without Serious drug-related CAEs

39

40

41

40

38

No statistical analysis provided for Number of Patients With Serious Drug-related CAEs

21. Other Pre-specified:

Number of Patients That Discontinued With CAEs [ Time Frame: 48 Weeks ]